A Study Describing Scratch and Sleep Patterns in Patients With Primary Biliary Cholangitis (Luminaria)

NCT07049887 | Completed

• 1 other identifier: CLIN-60190-466
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

This study will collect information from patients with Primary Biliary Cholangitis (PBC). PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). People living with PBC often face challenges like intense itching, trouble sleeping, and feeling constantly tired. These symptoms can make it hard for them to enjoy daily life and feel well overall. While itching and sleep patterns can be difficult to measure accurately based on recall and may lack precision, the main aim of this study is to use a digital health tool to assess the severity of itchiness and sleep patterns in people with PBC. The tool will take the objective measurement for people so they do not have to recall their scratch and sleep patterns. The total study duration for each patient will be about 91 days.

Conditions

Primary Biliary Cholangitis

Outcome Measures

Primary Outcomes (10)

• Number of Nocturnal Scratch Events

  Defined as the total number of scratch events detected during sleep periods, monitored using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.

  At weeks 0, 4, 8 and 12

• Frequency of Low- and High-Intensity Nocturnal Scratch Events

  Defined as the frequency of scratch events categorized into low- and high-intensity levels during sleep periods, as detected by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.

  At weeks 0, 4, 8 and 12

• Average Scratch Intensity Per Night

  Defined as the average intensity of scratch events per night, calculated from data recorded by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.

  At weeks 0, 4, 8 and 12

• Hourly Frequency of Nocturnal Scratch Events During Sleep

  Defined as the frequency of nocturnal scratch events occurring per hour during sleep periods, recorded using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.

  At weeks 0, 4, 8 and 12

• Average Duration of Scratch Events Per Night

  Defined as the average duration of scratch events occurring during sleep periods, calculated using data collected via the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.

  At weeks 0, 4, 8 and 12

• Total Duration of Scratch Behavior Per Patient During Sleep Periods

  Defined as the total duration of scratch events recorded for each patient during sleep periods using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.

  At weeks 0, 4, 8 and 12

• Total Sleep Duration (Hours)

  Defined as the total duration of sleep per patient, recorded by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.

  At weeks 0, 4, 8 and 12

• Duration of Wakefulness After Sleep Onset (WASO, Minutes)

  Defined as the total duration of wakefulness after the initial onset of sleep, measured using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.

  At weeks 0, 4, 8 and 12

• Duration of Wakefulness During Scratch Periods

  Defined as the total duration of wakefulness during scratch periods, monitored via the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.

  At weeks 0, 4, 8 and 12

• Average Sleep Duration Between Scratch Periods

  Defined as the average duration of sleep occurring between scratch periods, as measured by the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.

  At weeks 0, 4, 8 and 12

Secondary Outcomes (24)

• Demographic Data: Age at Enrollment

  At enrollment visit (Week 0, Day 1)

• Demographic Data: Sex at Enrollment

  At enrollment visit (Week 0, Day 1)

• Age at Diagnosis (As Available)

  At enrollment visit (Week 0, Day 1)

• Age at First Symptoms (As Available)

  At enrollment visit (Week 0, Day 1)

• Time Duration Since PBC Diagnosis

  At enrollment visit (Week 0, Day 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with PBC

You may qualify if:

• Aged 18 years or older at time of study enrollment.
• Confirmed diagnosis of PBC based on medical history and relevant clinical criteria, as determined by the study Investigator.
• Willingness and ability to wear the ADAM sensor during the specified time periods (7 nights across four 7-day periods).
• Able to read and write to ensure accurate completion of electronic PRO surveys.
• Able to access an internet-connected device for the completion of electronic PRO surveys.
• Able to provide signed, informed consent prior to collection of data.

You may not qualify if:

• Has already been enrolled in another clinical study.
• Has any dermatological conditions or severe comorbidities associated with pruritus as assessed by the investigators that may confound the measurement of scratch or sleep data.
• Has any extrapyramidal syndrome including Parkinsonism, essential tremor, astasia/abasia, cerebellar syndrome.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (3)

Arizona Liver Center

Chandler, Arizona, 85224, United States

Location

University of Miami School of Medicine, Center for Liver Diseases

Miami, Florida, 33136, United States

Location

UT Southwestern Medical Center, Department of Internal Medicine, Digestive and Liver Diseases

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: July 3, 2025
• Study Start: July 16, 2025
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
• Access Criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Locations

US (3)